- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582474
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response.
The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive.
An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease.
In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brice W Bicaba, MD
- Phone Number: +22670264393
- Email: bicaba_brico@yahoo.fr
Study Contact Backup
- Name: Maimouna Sow, MD
- Phone Number: +22670264393
- Email: beldoso@yahoo.fr
Study Locations
-
-
District Boulmiougou
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Ouagadougou, District Boulmiougou, Burkina Faso
- Recruiting
- Centre de Santé et de Promotion Sociale (Sandogo)
-
Contact:
- Brice W Bicaba, MD
-
Ouagadougou, District Boulmiougou, Burkina Faso
- Recruiting
- Centre de Santé et de Promotion Sociale (Secteur 16)
-
Contact:
- Brice W Bicaba, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older than 6 month
- Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
- Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure
Exclusion Criteria:
- Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
- Patients with severe disease requiring urgent care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dengue module and rapid diagnostic tests
|
Digital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
Time Frame: 4 months
|
This outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
|
4 months
|
Evaluation of the adherence to the different steps of the module
Time Frame: 4 months
|
This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
Time Frame: 4 months
|
4 months
|
|
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.
Time Frame: 4 months
|
4 months
|
|
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
Time Frame: 4 months
|
4 months
|
|
Positive predictive value of dengue rapid diagnostic test
Time Frame: 4 months
|
Polymerase chain reaction results will be used as the reference test.
|
4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brice W Bicaba, MD, Ministry of Health, Burkina Faso
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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